ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

040203-17

Study information

Scientific title

Acronym

Study hypothesis

Cognitive Behavioural Therapy (CBT) is effective in the psychological treatment of Panic Disorder (PD) and Agoraphobia (AG). However, CBT refers to a heterogeneous group of interventions, including psychoeducation, cognitive restructuring and exposure. The main active ingredients of CBT for panic disorder are yet not determined. Although exposure components appear essential to effective treatment of PD/AG, the debate related to the duration and format of exposure persist.

The current study compares two formats of a manualised CBT for panic disorder that differ only in the implementation of exposure therapy: 1. CbT refers to an exposure homework (only) condition; the therapist only assigns exposure.2. cBT refers to exposure that is therapist-guided; the therapist will accompany the patients in the exposure situation.

Hypotheses are:1. Both Cognitive Behavioural Therapy (CBT) groups will be significantly superior to the wait-list control group in all primary outcome measures.2. The in-vivo-cBT" group will be significantly better than the only-CbT group at post-treatment and at follow-up.

Ethics approval

The study was approved by the Ethics Committee of the Medical Faculty, Technical University Dresden on the 1st December 2006 (ref: EK 164082006).

Study design

Randomised clinical trial, intervention study with two active arms and a wait-list control group

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Panic disorder with and without agoraphobia

Intervention

Two treatment conditions are compared, both of them state-of-the-art-CBT:Condition A: CBT for panic disorder with therapist-guided in-vivo exposure exercises (in-vivo cBT-group)Condition B: CBT for panic disorder with exposure elements as an homework assignment, only (only-CbT group)

Secondary outcome measures

Overall trial start date

01/05/2007

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Outpatients 2. 18 to 65 years old3. Meet current Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria of panic disorder with/without agoraphobia4. Hamilton Anxiety Scale (HAMA) score more than or equal to 18 and a Clinical Global Impressions scale (CGI) score more than or equal to four5. Able to attend clinic on his/her own or accompanied by significant others6. Informed consent to participate and follow study procedures

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

450 (375 completers)

Participant exclusion criteria

1. DSM-IV Axis I diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and Axis II of borderline personality disorder2. DSM-IV Axis I disorders (other than panic disorder and agoraphobia) currently treated either by medications or non-pharmacological intervention3. Acute suicidality (Composite International Diagnostic Interview [CIDI] scale 2+)4. General medical contraindications